Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

This trial is conducted in Europe and Oceania.

The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

It had four arms (groups): NNC 90-1170 + Met (experimental), NNC 90-1170 + Met placebo (experimental), Met + NNC 90-1170 placebo (placebo comparator) and Met + Glim (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 145 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Duration of type 2 diabetes diagnosis at least one year. Body Mass Index (BMI) between 25-40 kg/m\^2, both inclusive.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial; impaired liver function; impaired renal function.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2002-08 with completion listed for 2002-12.

It ran at 41 sites in United Kingdom (14), Germany (7), Denmark (5), Australia (4), France (4) and Austria (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fasting plasma/serum glucose.

It also tracked 10 secondary outcomes, for example Home monitored fasting plasma glucose, Home monitored 7-point glucose profile, Fructosamine, Insulin, C-peptide and HbA1c (glycated haemoglobin A1c).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 145 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.